MAUDE Adverse Event Report: BIOMET 3I; IMPLANT MOUNT

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

Brand name not provided by the reporter.Device information not provided by the reporter.Device not returned to the manufacturer.510k unknown.Manufacturing date unknown.Since the lot number and device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which indicates that the device may have caused or contributed to the event, an additional report will be submitted.No item, lot or device being reported.

Event Description

It was reported that the mount was stuck and did not unscrew from the implant.Tried to remove the mount with a hand-piece connector and fractured the hexagon of the implant.Then tested with implant unscrewing ratchet and it was also not possible to remove the mount.The doctor removed the implant, sutured and rescheduled a new appointment for a new implant placement.

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.G4: date received by manufacturer was updated.G7: type of report was updated.H2: type of follow up was updated.H6: method code was updated to 4114.H6: results code was updated to 213.H10: narrative/data was updated.The reported device was not received for evaluation.The reported condition of stuck was not confirmed.Visual inspection of the reported device could not be performed as it was not returned.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Dhr review and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number or lot number could not be conducted as not enough information was provided for the reported device.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Type of Device: IMPLANT MOUNT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9526604
• MDR Text Key: 173221312
• Report Number: 0001038806-2019-01698
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 03/19/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XFOSM313
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR